IBI3014 in Participants With Unresectable Locally Advanced or Metastatic Solid Tumors

A Phase 1/2 Study of IBI3014 in Participants With Unresectable Locally Advanced or Metastatic Solid Tumors

This is a phase 1/2 multicenter, multi-regional, open-label, first-in-human study of IBI3014 in participants with unresectable locally advanced or metastatic solid tumors.

Study Overview

• Status: Recruiting
• Conditions: Unresectable Locally Advanced or Metastatic Solid Tumors
• Intervention / Treatment: Drug: IBI3014; Drug: IBI3014; Drug: IBI3014; Drug: IBI3014; Drug: IBI3014; Drug: IBI3014; Drug: IBI3014; Drug: IBI3014

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Wei Zhang; Phone Number: 15005136320; Email: wei.zhang02@innoventbio.com

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China, 350014
      • Recruiting
      • Fujian Cancer Hospital
      • Principal Investigator: Yu Chen
      • Contact: Yu Chen; Phone Number: 0591-6275 2224; Email: 13859089836@139.com
  • Hunan
    • Changsha, Hunan, China, 410000
      • Recruiting
      • Hunan Cancer Hospital
      • Principal Investigator: Yaqian Han
      • Contact: yaqian Han; Phone Number: 0731-89762021; Email: hanyaqian@hnca.org.cn
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200433
      • Recruiting
      • Shanghai Pulmonary Hospital
      • Principal Investigator: Shengxiang Ren
      • Contact: Shengxiang Ren; Phone Number: 021-65115006-2403; Email: harry_ren@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

• 1.Participants with the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol;
• 2.Male or female participants ≥ 18 years old;
• 3.Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;
• 4.Anticipated life expectancy of ≥ 12 weeks;
• 5.Participants, both male and female, who are either not of childbearing potential or who agree to use at least one highly effective method of contraception during the study (begin from screening or within 2 weeks prior to the first dose, whichever comes first, and continue until 6 months after the last dose of study drug).
• 6.Adequate bone marrow and organ function:
• 7.Has at least 1 measurable lesion per RECIST v1.1(at least 1 evaluable lesion for dose participants in dose escalation part);
• 8.Not a candidate for curable surgical resection or radical chemoradiation;

Exclusion Criteria

• 1.Drugs and other treatments to be excluded;
• 2.Has adverse reactions resulting from previous anti-tumor therapies, which have not resolved to Grade 0 or 1 toxicity according to NCI-CTCAE v5.0 (except for alopecia, fatigue, pigmentation and other conditions with no safety risk according to Investigators' opinion) prior to first administration of the study drug;
• 3.Prior use of Camptothecin-Derived agents (e.g., irinotecan, topotecan) or immune checkpoint inhibitor and documented adverse reaction which is severe and influence the safety assessment of participants.
• 4.Allergic or hypersensitive to other monoclonal antibodies and/or Camptothecin Derivative based therapy, or any ingredients of IBI3014;
• 5.Known symptomatic central nervous system (CNS) metastases. The following conditions could be considered enrollment: Participants with asymptomatic CNS metastases (which means no neural system syndromes, no need of corticosteroids treatment and diameter of metastases ≤ 1.5cm) or confirmed stable status according to Investigators' opinion after treatment, No midbrain, pons, cerebellum, meninges, medulla oblongata or spinal cord metastasis; and stable status for at least 4 weeks without new or enlarged metastases definitively confirmed by clinical evidence, and withdrawal of corticosteroids or anticonvulsant for at least 2 weeks prior to the first administration of study drug;
• 6.History of pneumonitis requiring corticosteroids therapy, or history of clinically significant lung diseases (e.g. Interstitial lung disease, non-infectious pneumonia, or uncontrolled lung disease such as pulmonary fibrosis, severe radiation pneumonitis and acute lung injury) or who are suspected to have these diseases by imaging at screening period;
• 7.Participants with a clinically significant (CS) cardiovascular disease or condition;
• 8.Participants with a significant gastrointestinal disease or condition,
• 9.Participants with biliary obstruction. Unless the blockage is treated locally, such as endoscopic stenting or percutaneous liver puncture and drainage, the total bilirubin is reduced below 1.5 times ULN;
• 10.Ascites, pleural effusion, or pericardial effusion with symptoms and requiring intervention;
• 11.Hepatic encephalopathy, hepatorenal syndrome or Child-Pugh grade B or more severe cirrhosis;
• 12.Significant malnutrition, such as the need for intravenous fluids; Malnutrition corrected for more than 4 weeks prior to the first administration of study drug is allowed;
• 13.Tumor invasion of surrounding important structures (such as mediastinal vessels, superior vena cava, trachea, esophagus, etc.) or at risk of gastrointestinal/respiratory fistula;
• 14.Uncontrolled or clinically significant infections
• 15.History of immunodeficiency disease, including congenital or acquired immunodeficiency diseases;
• 16.Had a history of organ transplantation, allogeneic bone marrow transplantation or hematopoietic stem cell transplantation;
• 17.Other uncontrolled active disease or acute or chronic diseases or abnormal laboratory test that may: increase risk of study participation or study drug administration, interfere with the interpretation of study results, and, disqualify the participant for study participation in the Investigator's judgment;
• 18.History of other primary malignant tumors;
• 19.Women who are considered pregnant or are lactating;
• 20.Under neurological, psychiatric disorder or social condition that affects compliance with study requirements, significantly increases the risk of adverse events, or affects participants' ability to provide written informed consent;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IBI3014; IBI3014 will be dosed until disease progression, toxicity intolerance, starting of new systemic anti-cancer treatment, withdrawal of consent, occurrence of other reasons for discontinuing study therapy, or treatment duration reaching the maximum of 24 months, whichever occurs first.	Drug: IBI3014; 12 mg/kg D1 IV Q3W; Drug: IBI3014; 6 mg/kg D1 IV Q3W; Drug: IBI3014; 1 mg/kg D1 IV Q3W; Drug: IBI3014; 15 mg/kg D1 IV Q3W; Drug: IBI3014; 9 mg/kg D1 IV Q3W; Drug: IBI3014; 3 mg/kg D1 IV Q3W; Drug: IBI3014; 20 mg/kg D1 IV Q3W; Drug: IBI3014; 18 mg/kg D1 IV Q3W

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR per RECIST v1.1 in Phase 1 dose expansion and Phase 2 dose optimization	The investigator assessed ORR per RECIST v1.1	2 years after LPI
The Safety profile of patients in Phase 1 dose escalation part、Phase 1 dose expansion and Phase 2 dose optimization	Number ofparticipants with adverse events (AEs)	2 years after LPI
Dose limiting toxicity (DLT) of IBI3014 in Phase 1 dose escalation	The occurance of Dose limiting toxicity (DLT) per protocol to establish MTD or RDEs	21 days after LPI
The Safety profile of patients in Phase 1 dose escalation part、Phase 1 dose expansion and Phase 2 dose optimization	Number ofparticipants with abnormal laboratorytests results	2 years after LPI
The Safety profile of patients in Phase 1 dose escalation part、Phase 1 dose expansion and Phase 2 dose optimization	Number ofparticipants with abnormal physical examination findings	2 years after LPI
The Safety profile of patients in Phase 1 dose escalation part、Phase 1 dose expansion and Phase 2 dose optimization	Number ofparticipants with abnormal vital signs	2 years after LPI

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of IBI3014	DOR, DoR, TTR, PFS as evaluated by investigator per RECIST v1.1 criteria and OS	2 years after LPI
PK profile of IBI3014	area under the curve (AUC)	2 years after LPI
Incidence and characterization of anti-IBI3014 antibodies	Rate of ADA and Nab	2 years after LPI
PK profile of IBI3014	area under the Cmax	2 years after LPI
PK profile of IBI3014	area under the Tmax	2 years after LPI
PK profile of IBI3014	area under the Clearance	2 years after LPI
PK profile of IBI3014	area under the t1/2 and others	2 years after LPI

Collaborators and Investigators

• Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: April 23, 2025
• First Submitted That Met QC Criteria: May 13, 2025
• First Posted (Actual): May 16, 2025

Study Record Updates

• Last Update Posted (Actual): January 29, 2026
• Last Update Submitted That Met QC Criteria: January 26, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: CIBI3014A101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No